State lawyer says drug compounders are violating the law

Published: Monday, April 8, 2013 at 5:51 p.m.

Last Modified: Monday, April 8, 2013 at 5:51 p.m.

The practice of drug compounding, which gained national attention after more than 50 people died from a contaminated medication last year, is now coming under fire by Florida regulators.

A lawyer for Florida's Joint Administrative Procedures Committee said in February that the Florida Pharmacy Board has erred in allowing pharmacists to compound and sell medicines to doctors without prescriptions from patients. The Joint Committee, which is made up of members of the Florida Legislature, reviews rules created by Florida agencies,

Joint Committee lawyer Marjorie Holladay said that the Pharmacy Board's rules that allow pharmacists to create and sell medications to doctors violate state and federal law and warned that she may file an objection with her committee.

Holladay's warning puts the Pharmacy Board and Florida lawmakers on a collision course.

Regulators across the nation, including here in Florida, began scrutinizing the controversial practice of compounding after a series of high-profile blunders by big drug compounders sickened hundreds and killed dozens more in recent years.

The most notorious of these cases involved the New England Compounding Center, a Massachusetts firm that produced thousands of vials of contaminated pain medicine. More than 50 people died and another 700 became sick in 20 states.

In Florida alone, 25 people fell ill after being injected with the tainted serums. Five died. All five received their contaminated medicine from pain management clinics in Ocala.

In the aftermath, critics panned the practice of compounding, saying that pharmacies like NECC were operating like drug manufacturers but without the same production standards and regulatory oversight.

By law, any pharmacist can create — or compound — a drug that is not otherwise commercially available for patients with prescriptions. They can also modify an existing drug for a patient who has a special need.

But instead of creating compounds to dispense to individual patients, many compounders do what is known as "anticipatory compounding," preparing large quantities of drugs for sale to doctors.

Critics say it amounts to manufacturing and distributing — not just dispensing — and compounders who work that way should then be regulated like any pharmaceutical company.

Compounders argue, however, that doctors don't know how much medicine they will need for their patients, so they order it in bulk.

The Food and Drug Administration, which has oversight of large pharmaceutical companies, has limited oversight of compounding pharmacies because of the way the law establishing the agency was drawn up in the 1930s. Each state regulates compounders and pharmacists, but oversight and regulations differ from state to state. In NECC's case, Massachusetts inspectors had found previous infractions but allowed the business to continue operating.

In the wake of the fungal meningitis outbreak, pharmacy regulators in many states began trying to define the limits of compounding. Among them is the Florida Board of Pharmacy.

In recent months, the Pharmacy Board has tried to rewrite some of its rules to make compounding pharmacists keep better records of how those medicines were used in doctors' offices.

But the effort drew the attention of Joint Committee lawyer Holladay. When she looked at how the Pharmacy Board was allowing Florida pharmacies to make drugs and sell them to doctors, she said the law was being broken.

"Instead of dispensing the drug to the ultimate consumer (the patient) ... it appears the pharmacy selling and delivering a compound drug to the (doctor) for office use is distributing the drug to a person other than the consumer (patient) ..." Holladay wrote to the Pharmacy Board in December. "Selling compounded prescription drugs to a practitioner for office use appears to constitute the wholesale distribution of a prescription drug."

The Florida Department of Health says that about 650 of Florida's 7,000 pharmacies make sterile, compound drugs.

The potential effect of the Joint Commission challenge was immediately seen by the Pharmacy Board and its attorney, David Flynn. Flynn is an assistant to the attorney general.

When the Pharmacy Board met in March to discuss the Holladay's warning, they directed Flynn to fight back.

But Flynn had reservations.

Flynn told the Pharmacy Board that the issue boiled down to a simple question: Were compounders dispensing like any other pharmacist, or were they distributing like a pharmaceutical company?

"So that's where I'm at. Your rule (for compounding and dispensing) at this point potentially contradicts the statute and that would be an invalid rule," Flynn told his board.

He added later, "If you're dispensing, you have to dispense to the patient."

Flynn then laid out some possible solutions.

They could stick with the current laws, he said, but not allow pharmacists to dispense drugs to doctors until they have a patient's name.

"There are a lot of laws and rules for that and one of them is you can dispense it, (but) we need a patient to track this to," Flynn said.

The Pharmacy Board could also go to the Florida Legislature and ask for a law that allows doctors to order large amounts of compounded medicines in advance of seeing their patients.

"If we were to go out there and try to formulate some kind of legislation for office-use compound(ing), it's not going to go anywhere," he said.

Such legislation "would have more bullet holes than even Swiss cheese" when lawmakers got through with it, he said.

And by proposing new legislation to address office-use compounding, Garcia said the attempt could end up banning the practice entirely.

"There is a need out there for (office-use compounding). The situation has been going on a lot of years," he said.

Flynn got his marching orders.

"I think we need to respond back that (the Joint Administrative Procedures Committee) is full of it," Garcia said.

Despite his reservations, Flynn penned a legal argument to the Joint Committee.

Flynn wrote that the agency had no problems with office-use compounding when the existing rules were created back in 2008.

He also argued that the Legislature gave the Pharmacy Board the power to establish rules and set standards for such things as compounding and dispensing.

He disagreed that compounding pharmacists are behaving like drug distributors. He said they are not acting as wholesalers because the drug is not intended for resale. Flynn said compound medicines are not resold but are administered to patients in the doctor's office.

If Holladay follows through on her warning to file a petition against the Pharmacy Board, the issue would come before the Joint Administrative Procedure Committee's 11 Florida senators and House representatives.

The Star-Banner asked to interview Flynn but Florida Department of Health spokeswoman Ashley Carr said Flynn would not be available to talk. The Pharmacy Board is part of the Florida Department of Health. The Star-Banner also telephoned the Joint Committee to speak with Holladay, but those telephone calls were not returned.

Meanwhile, in the Pharmacy Board's moves to reshape some of its pharmacy rules, its nine members agreed last week to ask the Legislature to expand the Pharmacy Board's powers beyond Florida. The board wants lawmakers to allow them to send inspectors into other states to inspect pharmacies doing business in Florida.

As for Florida pharmacies making sterile compounds here in Florida, the Pharmacy Board's 18 inspectors — five of whom inspect sterile compounding pharmacies — have their work cut out for them.

The Department of Health's chief investigator of pharmacies, Jeane Clyne, told the Pharmacy Board that of the 645 pharmacies that make sterile medicines, 416 have been inspected.

Until 2013, the Pharmacy Board never kept track of how many pharmacies in Florida made their medicines or how many made sterile medicines that risked contamination.

Clyne told the board that of the 416 facilities inspected, 65 had "serious violations" and would be inspected again next year.

The Star-Banner has requested from the Florida Department of Health copies of the inspections. So far, there has been no response.

<p>The practice of drug compounding, which gained national attention after more than 50 people died from a contaminated medication last year, is now coming under fire by Florida regulators.</p><p>A lawyer for Florida's Joint Administrative Procedures Committee said in February that the Florida Pharmacy Board has erred in allowing pharmacists to compound and sell medicines to doctors without prescriptions from patients. The Joint Committee, which is made up of members of the Florida Legislature, reviews rules created by Florida agencies,</p><p>Joint Committee lawyer Marjorie Holladay said that the Pharmacy Board's rules that allow pharmacists to create and sell medications to doctors violate state and federal law and warned that she may file an objection with her committee.</p><p>Holladay's warning puts the Pharmacy Board and Florida lawmakers on a collision course.</p><p>Regulators across the nation, including here in Florida, began scrutinizing the controversial practice of compounding after a series of high-profile blunders by big drug compounders sickened hundreds and killed dozens more in recent years.</p><p>The most notorious of these cases involved the New England Compounding Center, a Massachusetts firm that produced thousands of vials of contaminated pain medicine. More than 50 people died and another 700 became sick in 20 states.</p><p>In Florida alone, 25 people fell ill after being injected with the tainted serums. Five died. All five received their contaminated medicine from pain management clinics in Ocala.</p><p>In the aftermath, critics panned the practice of compounding, saying that pharmacies like NECC were operating like drug manufacturers but without the same production standards and regulatory oversight.</p><p>By law, any pharmacist can create — or compound — a drug that is not otherwise commercially available for patients with prescriptions. They can also modify an existing drug for a patient who has a special need.</p><p>But instead of creating compounds to dispense to individual patients, many compounders do what is known as "anticipatory compounding," preparing large quantities of drugs for sale to doctors.</p><p>Critics say it amounts to manufacturing and distributing — not just dispensing — and compounders who work that way should then be regulated like any pharmaceutical company.</p><p>Compounders argue, however, that doctors don't know how much medicine they will need for their patients, so they order it in bulk.</p><p>The Food and Drug Administration, which has oversight of large pharmaceutical companies, has limited oversight of compounding pharmacies because of the way the law establishing the agency was drawn up in the 1930s. Each state regulates compounders and pharmacists, but oversight and regulations differ from state to state. In NECC's case, Massachusetts inspectors had found previous infractions but allowed the business to continue operating.</p><p>In the wake of the fungal meningitis outbreak, pharmacy regulators in many states began trying to define the limits of compounding. Among them is the Florida Board of Pharmacy.</p><p>In recent months, the Pharmacy Board has tried to rewrite some of its rules to make compounding pharmacists keep better records of how those medicines were used in doctors' offices.</p><p>But the effort drew the attention of Joint Committee lawyer Holladay. When she looked at how the Pharmacy Board was allowing Florida pharmacies to make drugs and sell them to doctors, she said the law was being broken.</p><p>"Instead of dispensing the drug to the ultimate consumer (the patient) ... it appears the pharmacy selling and delivering a compound drug to the (doctor) for office use is distributing the drug to a person other than the consumer (patient) ..." Holladay wrote to the Pharmacy Board in December. "Selling compounded prescription drugs to a practitioner for office use appears to constitute the wholesale distribution of a prescription drug."</p><p>The Florida Department of Health says that about 650 of Florida's 7,000 pharmacies make sterile, compound drugs.</p><p>The potential effect of the Joint Commission challenge was immediately seen by the Pharmacy Board and its attorney, David Flynn. Flynn is an assistant to the attorney general.</p><p>When the Pharmacy Board met in March to discuss the Holladay's warning, they directed Flynn to fight back.</p><p>But Flynn had reservations.</p><p>Flynn told the Pharmacy Board that the issue boiled down to a simple question: Were compounders dispensing like any other pharmacist, or were they distributing like a pharmaceutical company?</p><p>"So that's where I'm at. Your rule (for compounding and dispensing) at this point potentially contradicts the statute and that would be an invalid rule," Flynn told his board.</p><p>He added later, "If you're dispensing, you have to dispense to the patient."</p><p>Flynn then laid out some possible solutions.</p><p>They could stick with the current laws, he said, but not allow pharmacists to dispense drugs to doctors until they have a patient's name.</p><p>"There are a lot of laws and rules for that and one of them is you can dispense it, (but) we need a patient to track this to," Flynn said.</p><p>The Pharmacy Board could also go to the Florida Legislature and ask for a law that allows doctors to order large amounts of compounded medicines in advance of seeing their patients.</p><p>But Pharmacy Board chairman Albert Garcia didn't like the latter proposal.</p><p>"If we were to go out there and try to formulate some kind of legislation for office-use compound(ing), it's not going to go anywhere," he said.</p><p>Such legislation "would have more bullet holes than even Swiss cheese" when lawmakers got through with it, he said.</p><p>And by proposing new legislation to address office-use compounding, Garcia said the attempt could end up banning the practice entirely.</p><p>"There is a need out there for (office-use compounding). The situation has been going on a lot of years," he said.</p><p>Flynn got his marching orders.</p><p>"I think we need to respond back that (the Joint Administrative Procedures Committee) is full of it," Garcia said.</p><p>Despite his reservations, Flynn penned a legal argument to the Joint Committee.</p><p>Flynn wrote that the agency had no problems with office-use compounding when the existing rules were created back in 2008.</p><p>He also argued that the Legislature gave the Pharmacy Board the power to establish rules and set standards for such things as compounding and dispensing.</p><p>He disagreed that compounding pharmacists are behaving like drug distributors. He said they are not acting as wholesalers because the drug is not intended for resale. Flynn said compound medicines are not resold but are administered to patients in the doctor's office.</p><p>If Holladay follows through on her warning to file a petition against the Pharmacy Board, the issue would come before the Joint Administrative Procedure Committee's 11 Florida senators and House representatives.</p><p>The Star-Banner asked to interview Flynn but Florida Department of Health spokeswoman Ashley Carr said Flynn would not be available to talk. The Pharmacy Board is part of the Florida Department of Health. The Star-Banner also telephoned the Joint Committee to speak with Holladay, but those telephone calls were not returned.</p><p>Meanwhile, in the Pharmacy Board's moves to reshape some of its pharmacy rules, its nine members agreed last week to ask the Legislature to expand the Pharmacy Board's powers beyond Florida. The board wants lawmakers to allow them to send inspectors into other states to inspect pharmacies doing business in Florida.</p><p>As for Florida pharmacies making sterile compounds here in Florida, the Pharmacy Board's 18 inspectors — five of whom inspect sterile compounding pharmacies — have their work cut out for them.</p><p>The Department of Health's chief investigator of pharmacies, Jeane Clyne, told the Pharmacy Board that of the 645 pharmacies that make sterile medicines, 416 have been inspected.</p><p>Until 2013, the Pharmacy Board never kept track of how many pharmacies in Florida made their medicines or how many made sterile medicines that risked contamination.</p><p>Clyne told the board that of the 416 facilities inspected, 65 had "serious violations" and would be inspected again next year.</p><p>The Star-Banner has requested from the Florida Department of Health copies of the inspections. So far, there has been no response.</p><p><i>Contact Fred Hiers at 867-4157 or fred.hiers@starbanner.com.</i></p>